Quality Control Specialist

Position Overview

The Quality Control Specialist plays a critical role in ensuring the accuracy, integrity, and compliance of laboratory data, documentation, and quality records. This position performs quality control reviews of study-related data and laboratory documentation, supports quality systems and document control processes, monitors laboratory quality metrics, and contributes to continuous improvement initiatives. The ideal candidate is highly detail-oriented, analytical, and committed to maintaining the highest standards of quality and regulatory compliance within a regulated laboratory environment.

Position Summary

The Quality Control Specialist is responsible for the review, verification, and maintenance of laboratory data, documentation, and quality records in accordance with established Standard Operating Procedures (SOPs), study protocols, analytical methods, and regulatory requirements. This role collaborates cross-functionally to ensure data integrity, compliance, and consistency across laboratory operations while supporting quality systems, laboratory metrics reporting, document control initiatives, and continuous improvement efforts.

The Quality Control Specialist contributes to departmental objectives by working independently, managing multiple priorities, completing assigned projects within established timelines, and maintaining effective communication with internal stakeholders.

Core Values & Behaviors

• Recognize, exemplify, and adhere to ICON's values centered on People, Clients, and Performance.
• Embrace and contribute to a culture of continuous improvement focused on enhancing efficiency, quality, compliance, and customer satisfaction.
• Demonstrate a strong commitment to quality, accuracy, integrity, and regulatory compliance.
• Collaborate effectively within a team environment and contribute to departmental and organizational goals.
• Communicate professionally and effectively with supervisors, colleagues, Project Leaders, Project Managers, and cross-functional teams.
• Prioritize workload effectively and manage time to meet deadlines.
• Maintain punctual and reliable attendance in accordance with company policy.
• Adhere to all safety procedures and maintain a safe working environment.

Key Responsibilities

Data Review & Compliance

• Perform quality control (QC) review of study participant results and laboratory run packets to ensure accuracy, completeness, and compliance with applicable SOPs, protocols, and regulatory requirements.
• Conduct review of Biomarker Reports and supporting study documentation to verify data accuracy and integrity.
• Perform QC review of validation documentation and associated records.
• Review methods, reports, study data, and supporting documentation for accuracy, consistency, completeness, and proper formatting.
• Identify, document, and communicate data discrepancies, quality issues, and compliance concerns in a timely manner.
• Assist with investigations and resolution of data and documentation discrepancies to support study integrity and quality objectives.
• Provide backup support for Incoming Materials review activities and QC review of Production Batch Records.
• Read, understand, and comply with SOPs, safety requirements, regulatory guidelines, and company policies.

Documentation & Records Management

• Maintain accurate, complete, and audit-ready records in accordance with regulatory, client, and company requirements.
• Support document control activities, including the creation, review, revision, maintenance, and archival of controlled documentation.
• Develop and support improvements to document control processes to enhance compliance, organization, efficiency, and traceability.
• Compile laboratory notebooks, departmental records, and supporting documentation for archival and regulatory compliance.
• Ensure documentation practices remain consistent, accurate, organized, and inspection-ready.

Quality Systems & Continuous Improvement

• Compile, maintain, analyze, and report laboratory quality metrics and key performance indicators.
• Develop and maintain tracking tools related to quality events, deviations, errors, and laboratory trends.
• Identify opportunities for process improvement through trend analysis, quality assessments, and operational observations.
• Support continuous improvement initiatives focused on quality systems, documentation practices, compliance, and operational efficiency.
• Respond to Quality Assurance observations and assist with corrective and preventive actions (CAPAs) as required.
• Participate in sponsor audits, regulatory inspections, and quality assessments as needed.

Cross-Functional Support

• Collaborate with laboratory, operations, project management, and quality teams to ensure timely completion of quality review activities.
• Support departmental projects and initiatives aimed at improving compliance, consistency, and overall laboratory performance.
• Perform additional duties as assigned by management.
• Participate in training and professional development activities to maintain knowledge of industry regulations and best practices.

Qualifications & Experience

Required Qualifications

• Minimum of five (5) years of laboratory experience in a regulated environment.
• Working knowledge of GxP regulations and applicable industry guidance documents.
• Proficiency with Microsoft Office Suite applications.
• Experience utilizing laboratory instrument data systems.
• Strong attention to detail and commitment to data integrity.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work independently while collaborating effectively across multiple departments.

Preferred Qualifications

• Experience using JMP statistical software for data analysis, trending, reporting, and visualization of laboratory quality metrics.
• Experience supporting sponsor audits, regulatory inspections, and quality assessments.
• Knowledge of laboratory quality systems, document control processes, data integrity requirements, and Good Documentation Practices (GDP).
• Experience analyzing quality metrics, deviations, investigations, CAPAs, and laboratory performance trends.
• Experience performing quality control reviews of scientific data, validation documentation, reports, and regulated laboratory records.
• Experience working within a pharmaceutical, biotechnology, contract research organization (CRO), or other regulated laboratory environment.
• Demonstrated ability to identify process improvement opportunities and contribute to continuous improvement initiatives.
• Experience collaborating cross-functionally with laboratory operations, Quality Assurance, Project Management, and other technical stakeholders.

Working Conditions

• Primarily laboratory and office-based work environment.
• Extended periods of computer-based work and document review.
• Ability to manage multiple priorities and deadlines in a regulated environment.
• May participate in audits, inspections, and cross-functional project activities as required.

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